Adashi Eli Y, Cohen I Glenn
From the Professor of Medical Science, Former Dean of Medicine and Biological Sciences, Brown University, Providence, RI (EYA); Attwood and Leslie Williams Professor of Law, Harvard Law School, Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, MA (IGC).
J Am Board Fam Med. 2023 Apr 3;36(2):366-368. doi: 10.3122/jabfm.2022.220290R1. Epub 2023 Feb 17.
On April 13, 2022, the Food & Drug Administration (FDA) issued a new draft guidance for industry for "developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials ." In so doing, the FDA reaffirmed the reality that racial and ethnic minorities remain underrepresented in clinical trials. FDA Commissioner Robert M. Califf, MD offered that the "U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health." Commissioner Califf went on to pledge that "achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities." This Commentary is dedicated to a thorough review of the new FDA policy and the implications thereof.
2022年4月13日，美国食品药品监督管理局（FDA）发布了一项针对行业的新指南草案，内容为“制定计划，让更多美国代表性不足的种族和族裔人群参与临床试验”。这样做时，FDA重申了一个现实，即种族和族裔少数群体在临床试验中的代表性仍然不足。FDA专员罗伯特·M·卡利夫医学博士表示，“美国人口日益多样化，确保种族和族裔少数群体在受监管医疗产品的临床试验中有有意义的代表性对公共卫生至关重要。”卡利夫专员接着承诺，“实现更大的多样性将是FDA的一个关键重点，以促进开发更好的治疗方法和更好的抗击疾病方式，这些疾病往往对不同社区造成不成比例的影响。”本评论致力于对FDA的新政策及其影响进行全面审查。
